The company at the center of a worldwide sleep aid device recall that left many sleep apnea patients restless is now being scrutinized by federal investigators on multiple fronts.
The Food and Drug Administration (FDA) announced that it has received more than 100 reports of deaths associated with popular sleep aids that many rely on around the world.
This latest revelation comes after the company behind the recalled product – Philips Respironics, a subsidiary of Royal Philips Corporation – recently informed shareholders that it had received subpoenas from the US Department of Justice, in part of an ongoing investigation into the Respironics recall.
Philips’ global voluntary recall of CPAP, BiPAP and ventilator devices was first announced almost a year ago in June 2021 after the company said there was carcinogenic noise canceling foam in the inside the device that could decompose and be inhaled unknowingly by its user. .
The FDA quickly labeled the recall Class 1: a designation reserved for the most serious type of recall.
FDA investigators later reported that the recall affected more than 15 million devices worldwide.
So many sleep apnea patients around the world have relied on the devices covered by the recall that Philips said it did not have enough parts to repair or replace the devices immediately, leaving some patients without much. options.
Patients like Edward Coleman, a 73-year-old Vietnam veteran from Michigan City, Indiana, who said his VA doctors prescribed a Philips DreamStation for his sleep apnea, regulating his breathing while he slept.
“My sleep is interrupted, you know, between two and three times a night,” Edward explained. “So it’s hard to really get a good night’s rest.”
Coleman said he’s still waiting for a replacement device, and since learning about the recall he now sleeps without any sleep aids after weighing the risks, but he’s worried about other veterans. who may not be aware of the problem.
“I want to reach out to fellow veterans so they can get the information they need to get their machines repaired or replaced,” Coleman told NBC 5 Responds. “That’s my biggest concern at this point.”
FDA: 124 suspected deaths linked to Philips devices
Coleman’s frustration, like many Americans, is not alleviated by the latest revelations from regulators.
Since April 2021, the FDA said it had received “more than 21,000 medical device reports (MDRs)” associated with the failure of noise-canceling foam inside Philips Respironics ventilators, BiPAP and CPAP devices.
These MDRs include 124 death reports associated with the recalled devices from Philips, the FDA said.
MDRs are a post-market surveillance tool used by the FDA to monitor medical devices, including reports of device-related malfunctions, injuries, or deaths.
These MDRs to the FDA include both mandatory reporting from Philips as well as voluntary reporting from healthcare professionals, consumers and patients, an FDA spokesperson said.
In response to the FDA’s findings, Philips told NBC 5 Responds that while the company is “investigating all allegations of device malfunction, death, or serious injury…the cause of an event generally cannot be determined from [the FDA’s MDR] notification system alone.
“Philips Respironics has received a surge in complaints allegedly associated with possible foam degradation,” after the company announced the recall in June 2021, a spokesperson told NBC 5 Responds.
The company said: “Philips regrets any inconvenience caused by this issue and we are committed to supporting the patient community who rely on our sleep and respiratory care solutions.”
The company also pointed to a study published by the American Journal of Respiratory and Critical Care Medicine (AJRCCM) last December that found patients using its devices did not have a higher risk of cancer.
The company said: “Independently from Philips Respironics, in December 2021, an analysis was published in the [AJRCCM] who did not find a higher risk of incident cancer in patients with obstructive sleep apnea (OSA) who used a Philips Respironics PAP device compared to OSA patients who used a PAP device from other manufacturers or patients OSA without treatment”,
NBC 5 Responds reached out to AJRCCM to verify study details, but did not hear back by the deadline.
DOJ Subpoenas and Prosecutions
Philips begins to feel increased pressure from the recall.
In a call last month with shareholders, Royal Philips CEO Frans van Houten said the company and its subsidiaries received subpoenas on April 8 from the US Department of Justice in connection with an ongoing recall investigation.
The DOJ subpoena was intended to “provide information relating to the events leading up to Respironics’ recall,” van Houten said. “Affected subsidiaries are cooperating with the agency.”
The CEO added that no specific allegations were raised in the subpoenas, but were just a general request for information about the recall.
The pressure is also mounting in courtrooms across the country.
In that same appeal, the company acknowledged that it currently faces 185 personal injury lawsuits and more than 100 class action lawsuits related to the device recall. These class actions are expected to be combined into two lawsuits this summer, the company said.
NBC 5 Responds reported in December that an FDA inspection found that nearly a decade ago the company had received more than 100 complaints related to defects in the sleep aid product, but no had not immediately acted.
In a previous statement, the company downplayed these FDA findings, saying that of the “limited complaints” it has received, each has been “evaluated and addressed,” on a case-by-case basis.
To learn more about Philips’ FDA inspection, Click here or look below.
A Food and Drug Administration (FDA) investigation alleges that for years, Philips Respironics knew about the health risks associated with its sleep aids, but did not immediately act. Reporting by Lisa Parker of NBC’s 5 Responds.
From the time it announced the recall, Philips said it planned to repair or replace each affected device, but that would take time.
To date, out of more than 15 million devices worldwide, the company said it has shipped 1.1 million replacement devices and repair kits to patients across the United States.
During the company’s earnings call in April, CEO van Houten said he hoped 90% of replacement machines would be sent to customers in 2022.
Below is a full list of affected Philips Respironics devices, according to the FDA:
CPAP and BiPAP devices
|Device type||Model name and number (all serial numbers)|
|Continuous ventilator, minimal ventilatory support, use of facilities||E30 (Emergency Use Authorization)|
|Continuous ventilator, non-life support||DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+|
|Non-continuous fan||SystemOne (Q series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto|
|Device type||Model name and number (all serial numbers)|
|Continuous fan||Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent|
|Continuous ventilator, minimal ventilatory support, use of facilities||A-Series BiPAP Hybrid A30 (not for sale in the US), A-Series BiPAP V30 Auto|
|Continuous ventilator, non-life support||BiPAP A40 A-Series, BiPAP A30 A-Series|
To register your affected device with Philips, and for more information on recalling and receiving a replacement device, Click here.
Do you have a consumer complaint? Call 1-844-NBC-REEE or Let us know, then NBC 5 Responds can help.